The (IRAD) International Registry for Acute Aortic Dissection
The purpose of this study is to collect information regarding your medical condition for a registry. The aim of the registry is to document a few important medical details of patients like you who were hospitalized for an acute aortic dissection. An aortic dissection is a serious condition in which a tear occurs in the inner layer of the body's main artery (aorta). Blood rushes through the tear, causing the inner and middle layers of the aorta to split (dissect). Based on the rarity of this disease and few guidelines regarding the most effective treatment for this disease, this registry aims to collect information from patients like you to study this disease. Patients from various hospitals in this country and in several other countries are being asked to participate. This information will help doctors understand more about acute aortic dissection. We believe this information will help to improve the treatment of patients like you in the future.
A sham-controlled pilot trial of focused ultrasound modulation of the globus pallidus interna in schizophrenia
The primary objectives of this study are to examine the tolerability of pulsed low-intensity focused ultrasound (PLIFUS) and its effects on brain function measured via fMRI functional connectivity and symptom response in individuals with schizophrenia. A neuronavigated single-element piezoelectric device will be utilized to noninvasively deliver transcranial PLIFUS sonication to the right globus pallidus interna, a brain region implicated in schizophrenia. We aim to enroll N=12 participants with schizophrenia in a random order, sham-controlled crossover trial of a single session of PLIFUS counterbalanced with a single sham sonication session, one week apart. After the participant provides written informed consent, a medical and psychiatric evaluation will be performed to determine eligibility for inclusion in the study, followed by a structural MRI to guide neuro-navigation. The first intervention visit will include a 10 minute PLIFUS sonication or sham sonication, preceded and followed by fMRI and an exit medical examination. Psychiatric symptoms will be assessed immediately prior to sonication/sham, during sonication/sham and 5 minutes, 30 minutes, 60 minutes, 1 day and 7 days after sonication/sham. The second intervention visit will consist of sonication or sham preceded and followed by fMRI in addition to symptom assessments and post-sonication/sham medical evaluation. Participants will be closely monitored during and after procedures for tolerability and adverse effects, including 1 and 7 day follow-up visits. The goal of this pilot study is to establish feasibility and tolerability and to determine whether the sonication procedure produces effects on the imaging biomarker and on symptoms prior to proceeding to therapeutic trials using repeated administration. If PLIFUS effects on fMRI and symptom ratings are not detected in the first 4 completers, subsequent participants will receive 3 sessions over 5 days.
Distal Ischemic Stroke Treatment with Adjustable Low-profile Stentriever
Evaluate the safety and effectiveness of the treatment with the investigational Tigertriever 13 device as compared to standard medical management.
Predictive Biomarker for Endoscopic Therapy in Chronic Pancreatitis
The purpose of this study is to use different measures to evaluate pain levels and pain responses in subjects with chronic pancreatitis to develop a biomarker that can help to better predict the response to medical and interventional therapies for pain. Biomarkers are measurable indicators of changes in the body (for example: pain, disease progression, treatment response).
Anomalous Aortic Origin of a Coronary Artery (AAOCA): Establishing a Multi-Institutional Registry
This is a retrospective and longitudinal cohort study. Subjects will be enrolled either when identified from medical records or when diagnosed with AAOCA. Baseline demographics, diagnoses, and test results will be obtained through retrospective chart review. Follow-up health-related information will be obtained through annual questionnaire. The project will be carried out at several participating CHSS member institutions, with the data stored and analyzed at the CHSS Data Center.
The Hancock Jaffe Surgical Antireflux Venous Valve Endoprosthesis (SAVVE) Study Trial
To assess the safety and effectiveness of the Hancock Jaffe VenoValve for the treatment of patients with deep venous valvular insufficiencyA prospective, non-blinded, single-arm multi-center pivotal study of the Hancock Jaffe VenoValve. All patients will receive optimized care (e.g., appropriate medications, compression therapy) throughout the study.The study will be conducted in accordance with the 2020 Standard ISO 14155 (Clinical investigation of medical devices for human patients - Good clinical practice), and other regulatory and legal requirements.
REBYOTA for the Prevention of Recurrence of Clostridioides Difficile Infection (CDI) in Adult Patients: An Observational Study
This is a prospective observational cohort study designed to collect data on patients who received REBYOTA for the prevention of rCDI in the routine care setting. As all data collected for this study are observational, the decision to prescribe REBYOTA is at the treating physician’s discretion and independent from the decision to enroll the patient in the study. Adult patients who receive a prescription for REBYOTA to prevent rCDI are eligible to enroll according to the inclusion and exclusion criteria described below. Patients must enroll in the study between prescription and administration. This allows time for patients to enroll while still conducting the baseline measurement of patient-reported outcomes (CDI-DaySyms™) prior to administration. REBYOTAFor each patient, the current or presenting rCDI episode will be defined as the CDI episode just prior to receiving REBYOTA. If a patient receives REBYOTA more than once, the first dose will be used to define the presenting rCDI and to assess REBYOTA effectiveness.Baseline period will be defined as the time period between the date REBYOTA is prescribed and the date REBYOTA is administered.Data will be collected from patients’ medical records after obtaining informed consent. Data about clinical history, CDI events (primary and recurrent: severity, treatment), CDI-related symptoms, treatments, medical procedures, AEs, and healthcare resource utilization (i.e., hospitalizations and re-admissions) will be collected through 6 months of follow-up from the date of REBYOTA administration.
Non-invasive biomarkers for neonatal outcomes in preterm infants
Despite modern advances that have greatly improved the health outcomes for preterm infants, the field of neonatology still lacks reliable prognostic tools for many disorders. Noninvasively-obtained samples (such as blood, trach aspirate, urine, saliva and stool samples) contain a wealth of biologic information in the form of DNA, RNA, proteins, and metabolites that can predict neonatal outcomes. Exosomes are small, membrane-bound extracellular vesicles (EVs) that are released by a variety of cells and involved in several cell-to-cell communication pathways. A proposed mechanism by which exosomes mediate cell signaling is via microRNAs (miRNAs), which are small, non-coding RNA segments that silence complementary messenger RNA (mRNA) segments. While exosomes have been characterized in biofluids from adults, few studies have examined the diagnostic value of biofluid exosomes.The objective of this study is to determine whether exosomes can be isolated from neonatal blood, urine, trach aspirate, saliva and stool samples, and if so, whether specific biomarkers (such as exosomal miRNAs) are associated with distinct neonatal pathologies such as chronic lung disease of prematurity (BPD: Bronchopulmonary dysplasia) or other neonatal inflammatory conditions. This is significant because findings could revolutionize the way preterm infants in neonatal intensive care units (NICUs) are monitored at the bedside. This exploratory, prospective study will be conducted with samples collected from the NYU Winthrop Hospital NICU. Specifically, we will measure biomarkers from non-invasive samples (Blood, urine, saliva and stool samples) in two groups; 1) preterm infants
A Real-world Patient Registry in Group 3 Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD)
The purpose of this patient registry is to observe, characterize, and capture real-world data from patients with Group 3 pulmonary hypertension associated with interstitial lung disease (PH-ILD). Group 3 pulmonary hypertension (PH), defined as PH associated with chronic lung disease or hypoxia, is associated with higher morbidity, mortality, and medical costs than similar patients without PH (Barberà 2015). Past registries focus solely on PH or chronic lung disease individually and lack clinically relevant data of the alternate group, making it necessary for acombined group registry.
Innovative NeurovaScular Product surveIllance REgistry (INSPIRE)
The purpose of this study is to collect information over time about how the approved Pipeline™ Shield Device is working and/or the outcome of the treatment. The study will be used to support post-market surveillance activities and post-approval studies (e.g., to collect safety and performance information). In addition, it will be used to obtain clinical evidence for the development and improvement of medical devices, therapies, device guidelines, patient services/solutions and provide clinical data to support health economics and clinical outcomes research. The Pipeline™ Shield Device is not investigational and the procedures being performed are not experimental.